Senior Associate Scientist: QC

3 months ago

Cranbury, United States Proclinical Staffing Full time

Senior Associate Scientist: QC- Contract - Cranbury, NJ

Proclinical is seeking a dedicated and technically proficient Senior Associate Scientist for Quality Control.

Primary Responsibilities:

The successful candidate will play a crucial role in supporting clinical manufacturing of a variety of Gene Therapy products. This role requires a deep understanding of analytical methodology for gene-based drug substances and products.

Skills & Requirements:

  • Degree in Biology, Molecular Biology, Virology, Life Sciences or equivalent
  • Relevant experience in QC or equivalent experience in the biotechnology industry
  • Preferred experience with Gene/Cell therapy products for clinical and commercial use
  • Excellent organizational skills
  • Ability to work independently with excellent problem-solving skills
  • Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing
  • Experience in AAV, and Lenti Viral Vector for gene therapy is highly preferred
  • Ability to interact across departments and functions

The Senior Associate Scientist: QC's responsibilities will be:

  • Execute assays using HPLC and CE-SDS
  • Operate q-PCR/ddPCR, Capillary Electrophoresis
  • Conduct routine testing of vectors and raw materials for release and stability
  • Support analytical and process development activities
  • Assist in general QC labs operations and functions
  • Document test execution in compliance with cGMP, maintain up-to-date QC records, logbooks, and notebooks
  • Review protocols, data summaries, reports for stability studies and validation
  • Assist with deviation, lab investigations, CAPA and Change Control

Compensation:

  • 40-45 USD per hour

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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